The Rhinovirus Hospitalization and Investigation of Nasal-airway Omics (RHINO) Study

NCT07342582 | Not Yet Recruiting

• 4 other identifiers: 2025-1076Protocol Version 12/21/25SMPH\PEDIATRICS\INFECT DIS1R01AI182200-01A1
• Study Type: observational
• Target: 670
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine the burden of Rhinoviruses (RVs) as a cause of acute, severe, respiratory illnesses leading to hospitalization. A community cohort of 120 children between 12 and 36 months of age will be enrolled in the first year of the study and followed (when well and sick) for 36 months to identify the circulating RVs and provide samples to establish a host nasal transcriptome differentiating clinical from subclinical RV infections. A hospitalized cohort of 450 infants and children will be enrolled during years 1 through 3 of the study and followed for the duration of their hospitalization to investigate the findings of the community cohort. An additional 100 healthy children aged 5-17 years will be enrolled for age-match comparison with the older hospitalized cohort.

Conditions

Rhinovirus

Keywords

infants; children; symptomatic; asymptomatic; lower respiratory tract infection

Outcome Measures

Primary Outcomes (2)

• Aim 1: Summary of Rhinovirus Types Identified in Community Cohort

  To test study hypotheses, the study team will identify the circulating RV types in symptomatic and asymptomatic children.

  data collected up to 36 months

• Aim 1: Unique Nasal Transcriptomic Signature of Clinical Rhinovirus Infections

  data collected up to 36 months

Secondary Outcomes (2)

• Aim 2: Summary of Rhinovirus Types Identified in lower respiratory tract (LRT) infections and upper respiratory tract infections (URI), Reported as Percent in Common

  data collected up to 36 months

• Aim 2: Proportion of Hospitalized Cohort with lower respiratory infections attributable to Rhinovirus

  data collected up to 36 months

Study Arms (3)

Younger Community Cohort (12-36 months of age)

Quarterly Surveillance Nasal Swabs and Nasal Swabs targeted around respiratory symptoms for up to 36 months of age, participants will provide one anterior and one mid-turbinate nasal swab sample

Diagnostic Test: Nasal Swab Healthy Surveillance; Diagnostic Test: Nasal Swab Sick Samples; Other: Sick Follow-up Survey

Hospitalized Cohort of Infants and Children

Generally healthy infants and children hospitalized for respiratory illness will provide one anterior and one mid-turbinate nasal swab sample

Diagnostic Test: Nasal Swab Hospitalized Cohort

Older Community Cohort (5 to 17 years of age)

Age-matched controls for older children in the Hospitalized Group, will be called upon as needed based on enrollment of hospitalized patients

Other: Older Cohort Control Group

Interventions

Nasal Swab Healthy Surveillance DIAGNOSTIC_TEST

Families will be asked to collect nasal swabs from their children during specified surveillance months (February, April, September, and December). Caregivers will be instructed to only collect surveillance samples during these months if and when children have been free of respiratory symptoms for at least two weeks prior to sampling. Caregiver surveys are part of quarterly surveillance.

Younger Community Cohort (12-36 months of age)

Nasal Swab Sick Samples DIAGNOSTIC_TEST

Caregivers will be instructed to watch for respiratory symptoms and collect nasal swabs 24-48 hours after symptom onset. Caregiver surveys are part of sick sample collection

Younger Community Cohort (12-36 months of age)

Nasal Swab Hospitalized Cohort DIAGNOSTIC_TEST

2 nasal swabs collected upon consent, one anterior and one mid-turbinate

Hospitalized Cohort of Infants and Children

Sick Follow-up Survey OTHER

Caregivers are surveyed 7-13 days after sick sample collection

Younger Community Cohort (12-36 months of age)

Older Cohort Control Group OTHER

Participants will be enrolled as needed based on enrollment of hospitalized patients

Older Community Cohort (5 to 17 years of age)

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Aim 1: Generally healthy male and female children 12 to 36 months of age living in Dane County and surrounding areas representative of the general demographics of the county. Aim 2a: Hospitalized male and female children between newborn and 17 years of age with acute onset lower respiratory tract infections. These children will span all demographic and socioeconomic groups. Aim 2b: Generally healthy male and female children 5 to 17 years of age living in Dane County and surrounding areas representative of the general demographics of the county.

You may qualify if:

• Parent/legal guardian is willing and able to provide informed consent in English.
• Willing to comply with all study procedures and be available for the duration of the study.
• Younger Community Group: Generally healthy children 12 to 36 months of age at the time of enrollment
• Older Community Group: Generally healthy children 5 to 17 years of age at the time of enrollment.
• Current patient within primary care system at UW Health
• Parent/legal guardian is willing and able to provide informed consent in English.
• Admitted to American Family Children's Hospital (AFCH) within the past 24 hours
• Children under 18 years of age at the time of enrollment
• Has a diagnosis of bronchiolitis, asthma exacerbation or CAP OR is an infant less than 6 months of age with fever greater than 38 degrees Celsius within 24 hours of hospital admission

You may not qualify if:

• Congenital or currently acquired immunosuppressive condition or medications (e.g., congenital immunodeficiency, Leukemia, Lupus)
• Congenital anomalies that might alter frequency of infection (e.g., unrepaired cleft palate, bronchial cyst, pulmonary sequestration)
• Presence of tracheostomy or gastrostomy tube
• Previously enrolled a different group in the study
• Other child in the same household already enrolled in the study
• Not suitable for study participation due to other reasons at the discretion of the investigators.
• Acute upper respiratory symptoms within the past week (7 days) at the time of enrollment
• A positive test for any virus other than RV within the 48 hours prior to and including admission.
• Born prematurely, less than 32 weeks 0 days gestational age

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

liquid media from nasal swabs only, induced sputum, blood, and residual clinical samples

Study Officials

• Ellen R Wald, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Nurses

CONTACT

608-228-4940; reserachnurses@pediatrics.wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data from this study may be requested from other researchers 3 years after the completion of the primary endpoint by contacting the study team at UW-Madison.

Locations

US (1)